Exoskeleton Training After Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Blood Pressure (mmHg)
研究概览
简要总结
The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.
详细描述
Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI.
Exoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A written clearance by the medical doctor .
- •Participants will have to be 1 year post-injury with any level of injury.
- •All participants will be between 18-70 years old, men/women,
排除标准
- •Participants with body weight greater than 220 lbs
- •Whole body T-scores less than -2.5 standard deviation will result in elimination from the program.
- •Hip width, upper leg length and lower leg length that do not fit in the robotic suit.
- •Previous unhealed fracture in both lower or upper extremities
- •Leg length discrepancy that is unlikely to be managed by having shoe inserts
- •High resting blood pressure greater than 130/80 mmHg
- •Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
- •Medical conditions prior enrollment similar to cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 2 or greater, or urinary tract infection or symptoms.
结局指标
主要结局
Blood Pressure (mmHg)
时间窗: 12 weeks
Resting blood pressure and post-exercise blood pressure will be measured every visit.
Walking time (minutes)
时间窗: 12 weeks
The robotic unit will measure standing up time, walking time and walking distance for every visit.
Oxygen uptake (l/min)
时间窗: 12 weeks
Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.
Body Composition (kg)
时间窗: 12 weeks
Body composition using dual energy x-ray absorptiometry anthropometrics' will be measured during sitting, standing and walking at the beginning and at the end of the training program.
次要结局
- Electromyography (EMG) activity of 6 muscle groups (mV)(12 weeks)
- 10 meter walk Test (m/sec)(12 weeks)
- Six minute-walk Test (meter)(12 weeks)
- Walking Index for Spinal Cord Injury II (WISCI II)(12 weeks)
- Mitochondrial health using near infra-red spectroscopy (seconds)(12 weeks)
研究者
Ashraf Gorgey
Director of SCI Research
McGuire Research Institute